Bioniche Presents Pre-Clinical Data on Anti-Cancer Agents and Immunomodulatory Molecules at International Congress of Immunology
BELLEVILLE ON, July 22, 2004 – Bioniche Life Sciences Inc. (TSX: BNC), a fully-integrated human and animal biopharmaceutical company, were among the presenters at the 12th International Congress of Immunology and 4th Annual Conference of FOCIS (Federation of Clinical Immunology Societies), jointly held in Montréal, Québec this week. Three presentations were made to the delegates attending the event, two relating to the Company’s proprietary Oligomodulators® and one relating to Mycobacterial Cell Wall-DNA Complex (MCC), the Company’s proprietary anti-cancer molecule.
Presentation #1: Immune Adjuvant Activity of Oligodeoxynucleotides Possessing GpA or GpT Motifs
Dr. Cristina Ciurli of Bioniche Therapeutics, presented results of a study that evaluated the potential of two Oligomodulators® containing GpA and GpT motifs as adjuvant for intramuscular and oral immunization against hepatitis B surface antigen. The results demonstrate that these Oligomodulators® can serve as immunomodulatory adjuvants by increasing the titer of antibody against this antigen and that Oligomodulators® with a phosphodiester backbone are more active than a phosphorothioate backbone.
“Our results show that these two Oligomodulators® may have potential for immunization against a wide variety of antigens, not only for hepatitis B surface antigen,” added Dr. Ciurli. “The unexpected adjuvant activity of our Oligomodulators® following oral administration offers significant advantage over the established intramuscular route of vaccination.”
Presentation #2: GpA or GpT Motif-Containing Oligodeoxynucleotides have a Co-Stimulatory Activity
Further data concerning Oligomodulators® were presented related to their ability to stimulate proliferation and cytokine induction in different murine cell populations. Mélanie Lehoux of Bioniche Therapeutics, presented results showing the ability of the GpA and GpT motif Oligomodulators® to function as co-stimulatory molecules for T lymphocytes.
Dr. Nigel C. Phillips, Senior Vice-President of Scientific Affairs and Chief Scientific Officer at Bioniche Life Sciences stated: “The ability of the GpA and GpT motif Oligomodulators® to act as co-stimulants for T lymphocytes as well as stimulating antibody production has significance for their use in both human and veterinary vaccines. It is of particular interest to note that chemical modifications of GpA and GpT oligodeoxynucleotides is not required to elicit adjuvant activity. The potential market for new adjuvant is large, including vaccination against bacteria, virus, parasites, and cancer.”
Presentation #3: Induction of Urinary Cytokines During Anti-Cancer Therapy with Mycobacterium phlei Cell Wall-DNA Complex (MCC): a Role for Monocytes, Macrophages, and Dendritic Cells
This presentation by Nathalie Saha of Bioniche Therapeutics, evaluated the capacity of MCC to induce the synthesis of cytokines following its intravesical administration to patients with carcinoma in situ (CIS) of the bladder and evaluated potential cellular target by studying its effect on human peripheral blood mononuclear cells and human dendritic cells. The results of this study showed that cytokine synthesis is stimulated following intravesical administration of MCC. The findings support a role for MCC in the stimulation of cytokine synthesis by bladder-associated monocytes and dendritic cells.
“These results are leading to a better understanding of the immunodulatory mechanism of action,” said Dr. Mario C. Filion, Head of Biomedical Research at Bioniche Life Sciences. “The findings demonstrate that MCC is a potent stimulator of cytokine synthesis by monocytes, macrophages, and dendritic cells. The known ability of MCC to directly induce apoptosis in bladder cancer cells may also contribute to the anticancer activity that has been observed in patients with bladder cancer.”
The urine samples mentioned in this presentation were obtained from patients with bladder cancer who had been treated with intravesical administration of MCC emulsion. The Principal Investigator of this study was Dr. Alvaro Morales, Professor of Urology and Oncology at Queen's University in Kingston, Ontario.
Bioniche, with Dr. Morales, has completed a Phase II clinical trial using MCC to treat superficial bladder cancer (SBC). In this study, 55 patients were enrolled, all of whom had been suffering for several years from carcinoma in situ (CIS), one of the most aggressive forms of SBC; their CIS was refractory to the traditional treatments of SBC (BCG and/or chemotherapy). During the study, the patients received one of two doses of MCC - either 4 mg or 8 mg - with evaluation at 3, 6, 12, and 18 months. The complete response at 12 months ranged (depending on the dose) from 43% to 64% of patients having no evidence of disease as demonstrated by cystoscopy, biopsy, and cytology. Bioniche is currently working with medical advisors and regulators in the design of a pivotal, multi-centre program in North America and Europe to confirm the efficacy and safety of MCC in patients with high-risk SBC.
“We are indeed fortunate at Bioniche to have such a talented group of researchers and affiliated clinicians,” noted Graeme McRae, President & CEO of Bioniche Life Sciences Inc. “Our robust research capabilities continue to generate a pipeline of technologies that we are developing into viable commercial treatments. We are committed to improving the quality of life for both humans and animals.”
Oligomodulator® is a proprietary technology of Bioniche Life Sciences Inc. Oligomodulator® oligodeoxynucleotides are a class of molecules with potential clinical anti-cancer activity and immune-modulating properties. They are composed of short phosphodiester or chemically-modified oligodeoxynucleotides that possess a range of novel pharmacological activities.
Mycobacterial Cell Wall-DNA Complex (MCC) is a non-viable cell wall composition prepared from the saprophytic microorganism Mycobacterium phlei. MCC acts as an immune stimulant towards normal mononuclear cells, and as a cell cycle arresting/proliferation inhibiting and apoptosis (programmed cell death)-inducing agent for cancer cells. MCC contains mycobacterial DNA, which appears to be responsible for both of these activities.